Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

Summary

EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®; now marketed as oxazepam (generic) only). This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine Use Disorder (CUD).

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Safety and Efficacy of EMB 001 in Subjects With Moderate-to-Severe Cocaine Use Disorder

Details

This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, study to compare the safety and efficacy of EMB-001 with a placebo control in approximately 80 subjects with moderate-to-severe CUD. Subjects will receive investigational medicinal product (IMP) during a 12-week, double-blind Treatment Period (Week 2 through Week 13) and a 1-week, double-blind Taper Period (Week 14). After undergoing study procedures during the Screening and Baseline Periods, subjects who meet inclusion and exclusion criteria will then be randomized in a 1:1 ratio (n=40/arm) to one of the following for the Treatment Period (weeks 2 - 13) on Study Day 8: - EMB-001 720 mg metyrapone/24 mg oxazepam mg BID, for a total daily dose of 1440 mg metyrapone and 48 mg oxazepam (Active Group) - Placebo BID, (Placebo Group) During the Taper Period (week 14), subjects in the Active Group will receive EMB-001 240/8 mg BID; and the Placebo Group will continue to receive placebo. Both groups will change from taking three capsules BID (twice daily) to one capsule BID (twice daily). There will be a follow-up visit for safety assessments at Week 18.

Keywords

Cocaine Use Disorder cocaine Disease EMB-001

Eligibility

You can join if…

Open to people ages 18-65

  • Provide written informed consent prior to any study procedures
  • 18 to 65 years of age
  • DSM-5 diagnosis of moderate-to-severe CUD
  • Seeking treatment for CUD. Subjects with past rehabilitation attempts are eligible if the most recent rehabilitation attempt ended at least 30 days prior to Screening
  • Female subjects must be of non-childbearing potential
  • Male subjects must agree to use accepted contraceptive regimens during the study and for at least 90 days after the last dose of the study drug

You CAN'T join if...

  • Any significant current medical conditions
  • Known hypersensitivity to or intolerance of oxazepam, metyrapone, or any benzodiazepine, or severe hypersensitivity reaction (e.g., angioedema) to any drug
  • Heightened likelihood of having adrenal insufficiency in the investigator's or designees' opinion
  • Current court-mandated treatment requirement for a substance-use disorder
  • Current DSM-5 moderate-to-severe substance use disorder, other than CUD, tobacco or caffeine
  • Current DSM-5 opioid or benzodiazepine use disorder of any severity

Locations

  • Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine accepting new patients
    San Diego California 92092 United States
  • Medical University of South Carolina accepting new patients
    Charleston South Carolina 29403 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Embera NeuroTherapeutics, Inc.
ID
NCT04501874
Phase
Phase 2
Study Type
Interventional
Last Updated